Recommended Principles to Guide Academy-Industry Relationships

370 Pages·2013·4.77 MB·English

by  Victor J. Stone

Recommended Principles to Guide
Academy-Industry Relationships
Purpose: To sustain and protect academic freedom, academic
professionalism, research integrity, and public trust.
Dedicated to the memory of
Victor J. Stone (AAUP President, 1982–84),
University of Illinois College of Law
AmericAn AssociAtion of University Professors
Distributed by the University of Illinois Press
To impart the results of their own and their fellow specialists’ investigations
and reflection, both to students and to the general public, without fear or
favor . . . requires (among other things) that the university teacher shall be
exempt from any pecuniary motive or inducement to hold, or to express,
any conclusion which is not the genuine and uncolored product of his own
study or that of fellow specialists. Indeed, the proper fulfillment of the work
of the professoriate requires that our universities shall be so free that no fair-
minded person shall find any excuse for even a suspicion that the utterances
of university teachers are shaped or restricted by the judgment, not of profes-
sional scholars, but of inexpert and possibly not wholly disinterested persons
outside of their own ranks. . . . To the degree that professional scholars, in
the formation and promulgation of their opinions, are, or by the character
of their tenure appear to be, subject to any motive other than their own sci-
entific conscience and a desire for the respect of their fellow experts, to that
degree the university teaching profession is corrupted; its proper influence
upon public opinion is diminished, and vitiated; and society at large fails to
get from its scholars, in an unadulterated form, the peculiar and necessary
service which it is the office of the professional scholar to furnish. “1915
Declaration of Principles on Academic Freedom and Academic Tenure,”
AAUP Policy Documents and Reports, Tenth Edition (Washington, DC: AAUP,
2006), 294–95.
ISBN 978-0-252-03824-2 (hardcover)
ISBN 978-0-252-07982-5 (paperback)
ISBN 978-0-252-09658-7 (eBook)
© copyright 2014 by the AAUP foundation
Washington, Dc
This report was largely written prior to the 2013 organizational restructuring
of the American Association of University Professors, but it is being published
in book form by the AAUP Foundation, a legal entity that was established
through the restructuring. The AAUP Foundation was organized for such
charitable and educational purposes, including establishing and supporting
principles of academic freedom and the quality of higher education in a free
and democratic society.
C ontents
Preface .......................................................................v
Glossary of acronyms and abbreviations .......ix
summary of recommendations ............................1
introduction .........................................................25
• Why the AAUP Is Issuing This Report ............................................25
• Academic Freedom: The Relationship between Individual Faculty
Rights and the Public Interest .........................................................29
• Embracing Diverse Missions: A Brief History of Academy-
Industry Relationships ....................................................................35
• The Growth of University-Industry Engagement:
1970 to the Present .........................................................................39
• What Accounts for Rising Levels of Academy-
Industry Engagement? ....................................................................47
The Bayh-Dole Act, the Stanford v. Roche Decision,
and Campus IP Management ......................................................47
Other Factors Driving Academy-Industry Engagement ...............63
• Types of Academy-Industry Research Collaboration ........................65
• The Benefits and Compromises of Academy-
Industry Engagement ......................................................................68
• Six Risks of Academy-Industry Engagement ....................................71
Risk 1: Violations of Academic Freedom and Researcher
Autonomy ..................................................................................71
Risk 2: Restricted Access to Data and Suppression of
Negative Results .........................................................................83
Risk 3: Threats to Open Science, Knowledge Sharing, and
Timely Publication .....................................................................89
Risk 4: Financial Conflicts of Interest (FCOI) .............................95
Risk 5: Research Bias and Unreliability
Associated with Corporate Funding ..........................................101
Risk 6: The Absence of Legal Protections to Safeguard
Research Integrity and Academic Freedom in Industry-
Sponsored Research Contracts ..................................................112
detailed discussion
of the 56 recommended PrinciPles .................. 117
• Part i. General Principles to Guide Academy-Industry
Relationships University-Wide (1–7) ............................................118
• Part ii. General Principles for Academic Education and
Training (8–10) .............................................................................136
• Part iii. General Principles for Management of Intellectual
Property (IP) (11–21) ....................................................................141
• Part iv. General Principles for Management of Conflicts
of Interest (COI) and Financial Conflicts of Interest (FCOI)
(22–31) .........................................................................................163
• Part v. Targeted Principles: Managing COI in the Context
of Clinical Care and Human Subject Research (32–35) .................189
• Part vi. Targeted Principles: Strategic Corporate Alliances
(SCAs) (36–48) .............................................................................194
• Part vii. Targeted Principles: Clinical Medicine, Clinical
Research, and Industry Sponsorship (49–56) .................................213
aPPendiX a: faculty handbook and
collective barGaininG aGreement
versions of the 56 PrinciPles ............................ 230
aPPendiX b: the sources of the 56 PrinciPles:
a summary of Which PrinciPles are neW,
versus those derived from aauP or other
Professional GrouPs’ recommendations ....... 247
endnotes ................................................................ 269
Preface
T
he American Association of University Professors (AAUP)
hereby issues this comprehensive report, Recommended
Principles to Guide Academy-Industry Relationships. Work
on this project began prior to the 2013 organizational
restructuring of the AAUP and at that time was funded
by a bequest from the estate of Victor J. Stone, a professor
in the College of Law at the University of Illinois at Urbana-Champaign
who served as AAUP general counsel and from 1982 until 1984 as AAUP
president, and by grants from the Open Society Foundations, the AAUP’s
Academic Freedom Fund, and the Canadian Association of University
Teachers (CAUT). This report is being published in book form by the AAUP
Foundation, which was established through restructuring to support academic
freedom and the quality of higher education in a free and democratic society.
Grants to the AAUP (before restructuring) and to the AAUP Foundation (after
restructuring) from a number of AAUP chapters and state conferences have
made the publication of this book possible. Donors include the chapters at
Connecticut State University, Michigan State University, Oakland University,
the University of New Hampshire, the University of Rhode Island, Rider
University, the University of Illinois at Urbana-Champaign, Utah Valley
University, and Wright State University, as well as the Assembly of State
Conferences, the Nevada Faculty Alliance, and the AAUP state conferences
in Alabama, California, Colorado, Connecticut, Illinois, Louisiana, Minnesota,
Missouri, New York, Ohio, Texas, and Washington. An updated list of donors
will be published in Academe.
This is perhaps the longest report the AAUP has ever produced, as well
as the most comprehensive in its scope and collation of empirical evidence.
It addresses issues that make the news weekly and regularly affect higher
education in the United States and across the world. The days when industry-
funded research was concentrated in a limited number of universities have
v
vi PREFACE
passed. Every type and size of institution now faces both the opportunities
and the responsibilities associated with industry-sponsored research relation-
ships. And such relationships occur throughout the world. As a result, faculty
members both here and abroad should find the report useful.
In the Summary of Recommendations, the report first outlines the 56
principles that the AAUP recommends all colleges and universities adopt, as
appropriate, in their governing and advisory documents to manage academy-
industry engagement. Appendix A provides condensed versions of the 56
principles in language suitable for faculty handbooks and collective bargain-
ing agreements. The precise language a campus chooses to employ might vary
according to the nature of the destination document, but much of the sample
policy language provided in Appendix A should prove directly transferable.
The lengthy Introduction to this report provides a detailed overview
of the current state of engagement between industry and the academy, and
discusses why the AAUP is issuing these 56 principles now. The main body of
the report analyses each of the AAUP’s 56 recommended principles individu-
ally, discussing its rationale, significance, and application in detail. A faculty
senate involved in reviewing, adopting, and implementing the recommenda-
tions should benefit from this detailed information.
Finally, Appendix B summarizes the provenance and specific sources for
each of the 56 principles, identifying whether each is drawn directly from
previous recommendations issued by the AAUP and other professional asso-
ciations, or whether it is new.
The report demonstrates the urgent need to give faculty governing bod-
ies greater authority over the principles and practices that regulate outside
funding, and over the disposition of inventions derived from faculty research.
But the report is by no means exclusively an assertion of faculty rights. It
specifies—and emphasizes—the responsibilities that must come with outside
funding, including public disclosure of financial conflicts of interest. Not all
will readily embrace these responsibilities, but the time has surely come when
every institution must debate and consider them.
This report began with a 2010 decision by Committee A on Academic
Freedom and Tenure to examine the issues surrounding industry-academy
engagement. A small group met early in 2011 to draft a set of sample recom-
mendations. The resulting discussion began to reveal the scope and challenges
of the project. Jennifer Washburn, an investigative journalist and author
familiar with the relevant literature, was invited to help prepare a full report
in collaboration with AAUP president Cary Nelson. Valuable advice came
from Ernst Benjamin, former AAUP general secretary, Cat Warren, editor of
Academe, and from the AAUP’s Department of Academic Freedom, Tenure,
and Shared Governance. A draft was then sent for review and comment to
PREFACE vii
three AAUP standing committees (Academic Freedom and Tenure, College
and University Governance, and Professional Ethics—chaired at the time,
respectively, by David Rabban, Larry Gerber, and Debra Nails) and to numer-
ous knowledgeable faculty members, administrators, and other authorities.
A substantial packet of responses included comments from Marcia Angell
(Medicine, Harvard University), Gerald Barnett (Research Technologies
Enterprise Initiative), Eric Campbell (Medicine, Harvard University),
Michael Davis (Philosophy, Illinois Institute of Technology), John R. Fuisz
(The Fuisz-Kundu Group LLP), Larry Gerber (History, Auburn University),
Gregory Girolami (Chemistry, University of Illinois at Urbana-Champaign),
Stanton A. Glantz (Medicine, University of California, San Francisco), Robert
Gorman (Law, University of Pennsylvania), Claire Katz (Philosophy, Texas
A&M University), Jonathan Knight (former head of the AAUP Department
of Academic Freedom, Tenure, and Shared Governance), Sheldon Krimsky
(Urban and Environmental Policy, Tufts University), Russ Lea (Vice President
for Research, University of South Alabama), Risa Lieberwitz (Labor and
Employment Law, Cornell University), Gerald Markowitz (Public Health
and American Social History, John Jay College of Justice), Debra Nails
(Philosophy, Michigan State University), Richard Nelson (International
Political Economy, Columbia University), Christopher Newfield (English,
University of California, Santa Barbara), David Rosner (History and Public
Health, Columbia University), Donald Stein (Medicine, Emory University),
Joerg Tiede (Computer Science, Illinois Wesleyan University), Paula A.
Treichler (Communications Research and Medicine, University of Illinois
at Urbana-Champaign), John Wilson (editor of Illinois Academe), and Stephen
Wing (Epidemiology, North Carolina State University). Washburn and
Nelson incorporated the responses as appropriate into a revised draft for
the standing committees to review. The consultant readers are not, of course,
responsible for the final recommendations, and providing their names here
does not imply their endorsement of all our recommendations, but thanks go
to them for their serious, detailed, and immensely helpful engagement with
the text.
A draft of the report was published online for comment in June 2012.
Among the additional responses received at that point was a detailed com-
mentary from the Association of University Technology Managers (AUTM).
Once again, the coauthors of the report, Washburn and Nelson, incorporated
appropriate comments into a revised version of the report. Final responsibil-
ity for wording and editorial changes, however, rests with Cary Nelson.
Jim Turk, the executive director of the Canadian Association of University
Teachers, participates in meetings of the AAUP’s Committee A on Academic
Freedom and Tenure. CAUT issued a much condensed (and adapted) version
viii PREFACE
of our Summary of Recommendations at the time we placed our full report
online for comment.
On a personal note, I would like to give special thanks to Steven Doran,
a PhD candidate in Communications at the University of Illinois at Urbana-
Champaign, who provided indispensable assistance with the numerous
editing, formatting, and computer challenges that accompany a text of this
length, and Paula A. Treichler, my lifelong partner, who brought her fearless
and unequalled editing skills to the task of polishing the report’s prose. Finally,
with a project of this scope, I would like to take the opportunity to recognize
the critical help we received from the AAUP’s national staff. Greg Scholtz
helped us manage the approval process and our requests from the Academic
Freedom Fund. Bob Kreiser, possessing wide knowledge of AAUP history
and principles, pointed us toward key documents and gave sage advice about
the 56 recommended principles. Mike Ferguson found a copy editor, design-
er, and printer and managed their work while also obtaining cost estimates
for the project. Ezra Deutsch-Feldman shepherded us through several chal-
lenges handling such a complex electronic document. Robin Burns shared
the public comment version of the report with reporters, while Katherine
Isaac distributed it to faculty members nationwide. Finally, I would like to
thank Martin Snyder, who helped to manage this massive enterprise with
flawless political and practical wisdom at every stage of the process.
Income from the sale of this book is divided equally between the
University of Illinois Press and the AAUP Foundation.
Cary Nelson
AAUP President, 2006–12
Glossary of Acronyms and
Abbreviations
AAMC—Association of Academic Medical Centers
AAMC—Association of American Medical Colleges
AAU—American Association of Universities
AAUP—American Association of University Professors
ABIM—American Board of Internal Medicine
ABL—Advanced Biological Laboratory
ACE—American Council on Education
ACCME—Accreditation Council for Continuing Medical Education
ACP—American College of Physicians
ADAMHA—Alcohol, Drug Abuse, and Mental Health Administration
AGB—Association of Governing Boards
AIDS—Acquired Immune Deficiency Syndrome
AIR—Academy-Industry Relationship
AMSA—American Medical Student Association
APA—American Psychiatric Association
ASIM—American Society of Internal Medicine
ATS—American Thoracic Society
AUTM—Association of University Technology Managers
BB&T—Branch Banking and Trust
BBC—British Broadcasting Corporation
BD—Bayh-Dole Act
BIP—Background Intellectual Property
BMJ—British Medical Journal
CAUT—Canadian Association of University Professors
CDC—Centers for Disease Control
CFR—Code of Federal Regulations
CHE—Chronicle of Higher Education
CIA—Central Intelligence Agency
CME—Continuing Medical Education
CML—chronic myelogenous leukemia
COGR—Council on Government Relations
COI—Conflict of Interest
CRADA—Cooperative Research and Development Agreement
DHHS—Department of Health and Human Services
DOD—Department of Defense
DOE—Department of Energy
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